COPDPhase 3NCT05213507
Inhaled Amikacin in Preventing AECOPD
A Phase 3 study testing aerosol inhaled Amikacin Sulfate Injection and conventional therapy in people with COPD and COPD Exacerbation, run by Shanghai Zhongshan Hospital at 5 sites in China.
Trial summary
The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of strong evidence on the effect of LRT bacterial decolonization on COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- aerosol inhaled Amikacin Sulfate Injection and conventional therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2022to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD according to GOLD 2021 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC) < 0.70 with the use of 400ug salbutamol)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted value with the use of 400ug salbutamol)
- A documented history of at least twice AECOPD in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics.
- In the stable stage of COPD.
- At least once positive result of amikacin sensitive Gram-negative bacteria by semi-quantitative sputum culture, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumonia, etc.
- Written informed consent must be obtained before any assessment is performed.
- Male or female adults aged 18-80 years.
Who cannot join
- Patients with concomitant pulmonary disease, including bronchiectasis, interstitial lung disease, asthma, etc.
- Patients with alpha-1 antitrypsin deficiency.
- Patients who have had AECOPD or acute exacerbation of any other diseases that required treatment with systemic glucocorticoids and/or antibiotics in the 4 weeks prior to screening.
- Patients with long-term oral corticosteroid use.
- Patients with Gram-negative bacterial infection requiring systemic treatment with antibiotics against Gram-negative bacteria.
- Patients who have participated in any interventional clinical trials in the 3 months prior to screening.
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- Patients who are allergic to amikacin or other aminoglycosides.
- Patients who have chronic hepatic, renal and gastrointestinal abnormality or malignant tumor, except for lung cancer, which could interfere with the assessment of the efficacy and safety of the intervention.
- Patients with mental diseases or cognitive disorders which could interfere with treatment and follow-up.
- Patients at high risk of being lost during the 3-month treatment and the 1-year follow up.
- Pregnant or nursing (lactating) women.
- Patients who are in critical conditions.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030
Jing Zhang, MD, PhD, 021-64041990, jingatlas@outlook.com
Shanghai Jingan District Central Hospital
Shanghai, Shanghai Municipality, 200040
Huifang Cao, 021-62474530
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality, 201100
Zhijun Jie, 021-64308151, jiezjlxh@163.com
Qingpu Branch of Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 201799
Chunling Du, 021-67009999, duchunling966@163.com
Wusong Branch of Shanghai Zhongshan hospital
Shanghai, Shanghai Municipality, 201900
Jingjing Li, 021-56162417
About this study
Official title: Inhaled Amikacin in Preventing Acute Exacerbation of Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): a Multicenter Clinical Study
The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of strong evidence on the effect of LRT bacterial decolonization on COPD. This study was designed to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) has become the third leading cause of death all over the world. Frequent acute exacerbations can even increase the mortality of COPD. Therefore, preventing the acute exacerbation of COPD (AECOPD) might improve prognosis.
About 74% of stable COPD patients had underlying pathogen colonization, mainly Gram-negative bacteria, in lower respiratory tract (LRT). Bacterial colonization can damage the airways of COPD patients, leading to disease progression. Further disruption of airway defense mechanisms promotes the adhesion and growth of bacteria in reverse. Eventually, a vicious circle is formed between LRT bacterial colonization and the progression of COPD. Thus, moderate to severe COPD patients were more likely to have LRT colonization, and patients with higher load of LRT bacterial colonization tended to have more frequent acute exacerbations. Decolonization of LRT bacteria may be able to control the progression of COPD and prevent AECOPD through breaking the vicious circle.
Instead of proving that long-term use of antibiotics in stable stage of COPD can prevent AECOPD, previous clinical trials have found that it can lead to the development of severe adverse reactions and the growth of LRT drug-resistant bacteria. It is probably because the main colonized LTR bacteria were not sensitive to those investigational drugs. Additionally, drugs were delivered systematically in those previous studies. Theoretically, inhalation administration can deliver the drug directly to the lungs, leading to higher drug concentrations in the lungs and less occurrence of systemic adverse reactions. Therefore, inhalation administration can well make up for the deficiencies of systematic administration. Studies on cystic fibrosis and bronchiectasis have yielded promising results of the safety and effectiveness of inhaled antibiotics for LRT bacterial decolonization. As COPD has similar manifestations to the two diseases, the promising results indicated the feasibility of decolonization of LRT bacteria to prevent AECOPD.
Previously, a multicentral clinical trial conducted by our research team preliminarily investigated whether nebulized Amikacin combined with conventional therapy could prevent AECOPD and disease progression of COPD. However, whether decolonization of LRT bacteria plays a role in these process remains unknown. The main purpose of this research is to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.
- Conditions
- COPD, COPD Exacerbation
- Being tested
- aerosol inhaled Amikacin Sulfate Injection, conventional therapy
- Keywords
- Amikacin, Respiratory Tract Diseases, Anti-Bacterial Agents, Anti-Infective Agents
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosol inhaled Amikacin Sulfate InjectionDrug
Also called Aerosol Inhaled investigation drug
0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.
conventional therapyOther
Also called Comparison Group
According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Amikacin plus Conventional Therapy | Experimental | 0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.
In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication.
Subjects will take conventional therapy at the same time. Receives: Drug: aerosol inhaled Amikacin Sulfate Injection; Other: conventional therapy |
| Conventional Therapy | Other | According to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long-term oxygen therapy. Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first COPD acute exacerbation
COPD acute exacerbation refers to the deterioration of daily symptoms, which requires treatment with antibiotics or systemic glucocorticoid therapy.
The first COPD acute exacerbations was defined as the date of occurrence of the first AECOPD starting from the day of the first dose to one day after the last visit.
Measured: 15 months
Secondary outcomes (8)
Number of the COPD acute exacerbations
COPD acute exacerbation refers to the deterioration of daily symptoms, which requires treatment with antibiotics or systemic glucocorticoid therapy.
The number of COPD acute exacerbations was defined as the number of all the AECOPD that occurs between the day of the first dose and one day after the last visit.
Measured: 15 months
Load of LRT colonized potential pathogenic bacteria in induced sputum
Induced sputum represents the specimen from LRT and should be processed within 6 hours after collection. Colonized bacteria are defined by the positive results of semi-quantitative culture.
Gram-negative bacteria, including Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae, the common bacteria involved in AECOPD, are defined as potential pathogenic bacteria.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Minimum inhibitory concentration (MIC) of colonized potential pathogenic bacteria in induced sputum
Induced sputum represents the specimen from LRT and should be processed within 6 hours after collection. Colonized bacteria are defined by the positive results of semi-quantitative culture.
Gram-negative bacteria, including Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae, the common bacteria involved in AECOPD, are defined as potential pathogenic bacteria.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Microbiome in induced sputum
Induced sputum represents the specimen from LRT and should be processed within 6 hours after collection.
Bacterial genomic DNA was isolated from sputum plugs of the same weight using the specific kits. The 16S bacterial ribosomal RNA genes were Polymerase Chain Reaction (PCR)-amplified with the appropriate controls against reagent contamination. Amplified DNA fragments were sequenced using the specific sequencing platform. Sequencing reads were processed and analyzed by the specific algorithm and software. The composition and diversity of microbiome are represented by major taxonomic groups at both phylum and genus levels. If necessary, Quantitative PCR for 16S rRNA gene will be performed to validate the results of sequencing. By using these methos, we can detect the microbiome's composition and its shift.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Forced Expiratory Volume in 1 Second
Pulmonary function assessments were performed using centralized spirometry according to international standards. FEV1 was measured 15 minutes after inhaling 400 ug salbutamol.
Measured: Baseline, 3 months, 15 months
COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is an 8-item uni-dimensional measure of health status impairment in COPD, containing 6 grades from 0 to 5.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
modified Medical Research Council (mMRC) scale
The modified Medical Research Council (mMRC) scale is a simple and powerful tool to evaluate the breathlessness, containing 5 grades from 0 to 4.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Number of Patients with Adverse Events, Serious Adverse Events, and Death
The overall rate of adverse events reported from the day of the first dose to the last visit. Laboratory examinations, including blood routine, urine routines and hepatorenal function, and electrocardiogram are performed in each visit in order to evaluate the safety of interventions.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, MD, PhD, Principal investigator, Zhongshan hospital, Shanghai Medical College, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213507
- Sponsor's protocol ID
- B2021-766
- Other IDs
- DGF501035/017
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Amikacin in Preventing Acute Exacerbation of Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): a Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05213507
- Acronym / sponsor ID
- B2021-766
- Conditions
- COPD, COPD Exacerbation
- Keywords
- Amikacin, Respiratory Tract Diseases, Anti-Bacterial Agents, Anti-Infective Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of strong evidence on the effect of LRT bacterial decolonization on COPD. This study was designed to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) has become the third leading cause of death all over the world. Frequent acute exacerbations can even increase the mortality of COPD. Therefore, preventing the acute exacerbation of COPD (AECOPD) might improve prognosis.
About 74% of stable COPD patients had underlying pathogen colonization, mainly Gram-negative bacteria, in lower respiratory tract (LRT). Bacterial colonization can damage the airways of COPD patients, leading to disease progression. Further disruption of airway defense mechanisms promotes the adhesion and growth of bacteria in reverse. Eventually, a vicious circle is formed between LRT bacterial colonization and the progression of COPD. Thus, moderate to severe COPD patients were more likely to have LRT colonization, and patients with higher load of LRT bacterial colonization tended to have more frequent acute exacerbations. Decolonization of LRT bacteria may be able to control the progression of COPD and prevent AECOPD through breaking the vicious circle.
Instead of proving that long-term use of antibiotics in stable stage of COPD can prevent AECOPD, previous clinical trials have found that it can lead to the development of severe adverse reactions and the growth of LRT drug-resistant bacteria. It is probably because the main colonized LTR bacteria were not sensitive to those investigational drugs. Additionally, drugs were delivered systematically in those previous studies. Theoretically, inhalation administration can deliver the drug directly to the lungs, leading to higher drug concentrations in the lungs and less occurrence of systemic adverse reactions. Therefore, inhalation administration can well make up for the deficiencies of systematic administration. Studies on cystic fibrosis and bronchiectasis have yielded promising results of the safety and effectiveness of inhaled antibiotics for LRT bacterial decolonization. As COPD has similar manifestations to the two diseases, the promising results indicated the feasibility of decolonization of LRT bacteria to prevent AECOPD.
Previously, a multicentral clinical trial conducted by our research team preliminarily investigated whether nebulized Amikacin combined with conventional therapy could prevent AECOPD and disease progression of COPD. However, whether decolonization of LRT bacteria plays a role in these process remains unknown. The main purpose of this research is to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Amikacin plus Conventional Therapy | Experimental | Drug: aerosol inhaled Amikacin Sulfate Injection, Other: conventional therapy0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months. In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication. Subjects will take conventional therapy at the same time. |
| Conventional Therapy | Other | Other: conventional therapyAccording to the subjects' personal characteristics and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled glucocorticoids and long-term oxygen therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with COPD according to GOLD 2021 (The ratio of post-bronchodilator forced expiratory volume in 1 second (FEV1) to force vital capacity (FVC) < 0.70 with the use of 400ug salbutamol)
- Moderate to very severe airflow limitation (post-bronchodilator FEV1 < 80% of the predicted value with the use of 400ug salbutamol)
- A documented history of at least twice AECOPD in the previous 12 months that required treatment with systemic glucocorticoids and/or antibiotics.
- In the stable stage of COPD.
- At least once positive result of amikacin sensitive Gram-negative bacteria by semi-quantitative sputum culture, including Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumonia, etc.
Key exclusion criteria (12 listed)
- Patients with concomitant pulmonary disease, including bronchiectasis, interstitial lung disease, asthma, etc.
- Patients with alpha-1 antitrypsin deficiency.
- Patients who have had AECOPD or acute exacerbation of any other diseases that required treatment with systemic glucocorticoids and/or antibiotics in the 4 weeks prior to screening.
- Patients with long-term oral corticosteroid use.
- Patients with Gram-negative bacterial infection requiring systemic treatment with antibiotics against Gram-negative bacteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerosol inhaled Amikacin Sulfate InjectionAlso: Aerosol Inhaled investigation drug0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months. | Drug | Inhaled Amikacin plus Conventional Therapy |
| conventional therapyAlso: Comparison GroupAccording to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy. | Other | Conventional Therapy, Inhaled Amikacin plus Conventional Therapy |
Primary outcome
Time to the first COPD acute exacerbation
Time frame: 15 months
COPD acute exacerbation refers to the deterioration of daily symptoms, which requires treatment with antibiotics or systemic glucocorticoid therapy. The first COPD acute exacerbations was defined as the date of occurrence of the first AECOPD starting from the day of the first dose to one day after the last visit.
8 secondary outcomes
Number of the COPD acute exacerbations
Time frame: 15 months
Load of LRT colonized potential pathogenic bacteria in induced sputum
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Minimum inhibitory concentration (MIC) of colonized potential pathogenic bacteria in induced sputum
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Microbiome in induced sputum
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Forced Expiratory Volume in 1 Second
Time frame: Baseline, 3 months, 15 months
COPD Assessment Test (CAT) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
modified Medical Research Council (mMRC) scale
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Number of Patients with Adverse Events, Serious Adverse Events, and Death
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zhang, MD, PhD principal investigator
Zhongshan hospital, Shanghai Medical College, Fudan University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aerosol inhaled Amikacin Sulfate Injection and conventional therapy in people with COPD and COPD Exacerbation, run by Shanghai Zhongshan Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang, MD, PhD (+86-13472782754, zhang.jing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first COPD acute exacerbation (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.